Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

Completed · Phase 3

Conditions studied: Community Acquired Pneumonia

In brief

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia

Key facts

Study ID

NCT02813694

Run by

Nabriva Therapeutics AG

People needed

738

Starts

2016-08-01

Expected to finish

2018-01-01

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each subject must:
• Be male or female at least 18 years of age.
• Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
• Have an acute illness (less than or equal to 7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):
• Dyspnea.
• New or increased cough.
• Purulent sputum production.
• Chest pain due to pneumonia.
• Have at least 2 of the following vital sign abnormalities:
• Fever (body temperature > 38.0 °C (100.4 °F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature < 35.0 °C (95.0 °F) measured orally or equivalent temperature from an alternate body site).
• Hypotension (systolic blood pressure < 90 mmHg).
• Tachycardia (heart rate > 100 beats/min).
• Tachypnea (respiratory rate > 20 breaths/min).
• Have at least 1 other clinical sign or laboratory finding of CABP:
• Hypoxemia (i.e., O2 saturation < 90 % on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 < 60 mmHg).
• Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness).
• White blood cell (WBC) count > 10 000 cells/mm3 or < 4 500 cells/mm3 or >15 % immature neutrophils (bands) regardless of total WBC count.
• Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).
• Have a Pneumonia Outcomes Research Team (PORT) Risk Class of II, III, or IV and be an appropriate candidate for oral antibiotic therapy as treatment for the current episode of CABP.

You may not qualify if…

• Each subject must NOT:
• Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization.
• Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens.
• Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted.
• Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., MRSA, Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung).
• Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).
• Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).

Where it is running

• Site 1065 — Fresno, California, United States
• 1078 — Northridge, California, United States
• Site 1072 — Oxnard, California, United States
• Site 1070 — Sacramento, California, United States
• 1079 — Sherman Oaks, California, United States
• Site 1053 — Sylmar, California, United States
• Site 1064 — DeBary, Florida, United States
• Site 1052 — DeLand, Florida, United States
• 1076 — Miami, Florida, United States
• Site 1051 — Michigan City, Indiana, United States
• Site 1057 — Natchitoches, Louisiana, United States
• Site 1073 — New Bedford, Massachusetts, United States
• Site 1055 — Detroit, Michigan, United States
• Site 1062 — Detroit, Michigan, United States
• Site 1068 — Royal Oak, Michigan, United States
• Site 1058 — St Louis, Missouri, United States
• Site 1054 — Butte, Montana, United States
• Site 1067 — Lima, Ohio, United States
• Site 1056 — Rapid City, South Dakota, United States
• 1077 — Hendersonville, Tennessee, United States
• Site 1060 — Houston, Texas, United States
• Site 1069 — Houston, Texas, United States
• Site 1066 — Splendora, Texas, United States
• Site 1059 — Charlottesville, Virginia, United States
• 1080 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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